Randomized controlled trials are the gold standard for determining which treatments are superior. More and more, clinicians of all specialties are demanding that randomized trials show new treatments, such as surfactant and ECMO, to be superior to current therapy (or no therapy) before the new treatments are adopted.

This workshop will cover principles of clinical trials including defining the question, assessing outcomes, defining the study and control treatments, single- versus multi-center trials, reasons for and methods of randomization, eligibility and exclusions, blinding, analysis strategies, and early stopping. The format will be didactic with extensive open discussion. Real world examples of "what can happen if you don't watch out" will be utilized. Participants are encouraged, although not required, to bring an idea for a possible clinical trial. We will use these ideas as examples during the discussion. Statistical knowledge is definitely not required.

Mark A. Klebanoff, Director, Division of Epidemiology, Statistics and Prevention Research, NICHD, NIH, Bethesda, MD

Little is known about the etiology, treatment, or sequelae of infantile colic. Research has identified potential effects that colic may have on child development, parent-child relationships and family functioning. This year's SIG will describe a multidisciplinary outpatient clinical model of care developed to diagnose and treat infants with crying, sleeping, feeding and associated behavior problems. Pamela C. High, J. E. Twomey, C. F. Z. Boukydis, C. L. Miller-Loncar, V. P. Dalzell & B. M. Lester, all of Brown University School of Medicine, will present "What To Do When Colic Makes You Want To Cry: A Multi-Disciplinary Approach". Their treatment team is comprised of pediatricians, psychologists, and a clinical social worker. Clinical interviews, behavioral questionnaires and 24-hour infant behavior diaries are used to diagnose and to monitor treatment. The clinical approach presented in the workshop illustrates the benefits of integrating psychological and behavioral pediatric services into a single service for infants and their families. The presenters will describe how they examine the infant's crying and its interrelation with feeding, sleep schedules, and parent-infant interactions. An additional emphasis of the presentation is on treating the presenting problems and preventing future behavioral difficulties. Data looking at a possible relationship between maternal depression and colic from a sample of 90 families with infants with excessive crying will be presented. Data on diagnosis, treatment and outcomes from 50 infants recently referred to our clinic will be presented and 6 cases will be used to demonstrate application of this model. An important part of the presentation will be discussion of this technique's use in primary care settings.

The focus of this group is on advancing the recognition, assessment, and management of pain in children. The orientation of the SIG is not on how to manage pain but on the development of strategies that will promote change in health care institutions and individual practice patterns. Presentations may concern the management of pain in specific age groups (e.g. infancy), specific settings (e.g. ambulatory, ED, NICU), specific populations (e.g. developmentally disabled), individuals with specific pain problems (sickle cell, cancer, RSD, headache) or on strategies to promote changes in institution or individual attitudes and practice. The SIG will allow a forum for discussion and sharing of ideas with the goal of reducing pain in pediatric practice.

Approaches to the diagnosis, prevention, and treatment of chronic conditions in childhood and adolescence have changed greatly with greater survival of most children, even with severe conditions. Thus, for most children, new issues include preparation for adulthood rather than expectation of early death. Community pediatricians have increasing numbers of children with chronic conditions in their practices and thereby face new challenges in the care of these children and their families. Advances in molecular biology and genetics will lead to more effective ways to identify and treat many conditions. At the same time, children and adolescents face a great rise in new epidemics of chronic conditions, with marked increases in obesity, asthma, Type 2 diabetes, mental health conditions (especially ADHD and depression). This session will examine new advances in the biology of chronic conditions, important changes in epidemiology, consideration of important outcomes for children and adolescents with chronic conditions, and new efforts to improve their pediatric care.

Overview

New Morbidities: Clinical and Social Changes in Childhood Chronic Conditions
James M. Perrin, Mass General Hospital for Children, Harvard Medical School, Boston, MA

Prospects for New Treatments
Alan B. Ezekowitz, Massachusetts General Hospital, Boston, MA

Improving the Care of Children with Chronic Illness
Carole M. Lannon, AAP liaison, National Initiative for Children's Helathcare Quality, University of North Carolina, Chapel Hill, NC

Outcomes of Chronic Conditions: What Should We Measure?
Ruth E. K. Stein, Albert Einstein College of Medicine/Children's Hospital of Montefiore, Bronx, NY

The U.S. is experiencing an epidemic of pediatric obesity. However, many primary care providers report that obesity is one of the most frustrating and difficult problems in their practices. In this workshop, we will provide practical strategies for evaluating and treating obese children in primary care. To maximize learning and relevance the session will be split. During the first third of the session, we will present expert committee recommendations for evaluation and behavioral treatment strategies. We will address skills for identification of obesity, screening for both rare endogenous causes of obesity and more common obesity-associated conditions or risk factors, assessment of emotional and psychosocial states, eating and activity assessment, and indications for consultation with an obesity specialist. For treatment, we will address the most successful strategies for diet and physical activity counseling, changing the household environment, self- monitoring, goal setting and contracting, parenting skills training, maintenance and relapse prevention, and the potential role of drug therapies. The second two-thirds of the session will consist of case discussions and group problem solving. Cases will be provided but attendees will be asked to bring their own cases as well. Several additional experienced obesity specialists will also be present to participate in the case discussions.

T. N. Robinson and S. E. Barlow, Department of Pediatrics, Stanford University, Palo Alto, CA & Department of Pediatrics, St. Louis University School of Medicine, St. Louis, MO

Over 75,000 children, from 36 countries, have been adopted by U.S. families since 1990. During 1998 alone, almost 16,000 children have been internationally adopted. It is quite likely that the primary care provider will encounter at least one internationally adopted child in his or her practice. While most of these children may appear healthy and well nourished, more than 50% have an undiagnosed medical condition at the time of the initial evaluation in the United States, regardless of age, sex, or country of origin. This workshop is designed to educate and alert the participants to the unique medical needs of these children so that early treatment and intervention is optimized. The workshop will familiarize the primary care provider working with international adoptees and will clarify his or her role in caring for the internationally adopted child. The first part of the workshop will focus on the following topics: 1) review medical records (photos, video) of the child from abroad, 2) travel preparation for parents, 3) post-adoptive medical screening, diagnoses, and treatment of medical conditions, 4) immunizations, 5) assessment of growth, development and nutrition, 6) coordinating care of special-needs children, and 7) guidance on adjustment problems, language delays, preparation for preschool and school, adoption procedures, cultural issues. The second part of the workshop will consist of small group discussions involving several case studies. The workshop team consists of general pediatricians, infectious disease experts, developmentalists, and international adoption clinic directors who provide services to a large number of internationally adopted children and their parents throughout the country. Written materials reviewing workshop concepts and a list of adoption clinics will be distributed.

E. E. Schulte, J. E. Aronson, L. M. H. Albers, S. Blatt; Children's Hospital at Albany Medical College, International Adoption Medical Consultation Services, Mineola, Children's Hospital, Boston, Department of Pediatrics, Syracuse

The repercussions of violence affect pediatric patients and their families every day. Many residency training programs struggle with how to address this new epidemic. This workshop presents a model of a creative, comprehensive violence assessment and prevention curriculum, encouraging medical educators to explore new teaching methods. We hope to stimulate a lively discussion of educational strategies: didactic presentations, multimedia demonstrations, standardized patient interviews, community resource displays and evaluation methods. Attendees will be trained in case-based role-play scenarios to facilitate learners' communication skills within the patient-physician encounter. The workshop will offer specific didactic outlines and examples of pertinent videotapes and community resource displays as springboards for conversation regarding improvement of resident violence education. The model suggests one evaluation method that reinforces the newly acquired competencies via the creation of learner contracts. Small group discussions will be used to generate new ideas in violence-related curriculum development and evaluation.

Shannon Phillips, Jill Mazurek, Mary Ciccarelli, Marilyn Bull, Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN

Primary care physicians increasingly encounter behavior problems (e.g., noncompliance, sleep problems, and ADHD), but sometimes these problems do not resolve with an exclusive child-symptom centered approach. Furthermore, physicians are encountering interaction-psychosocial problems (e.g., relationship and communication problems, family affective disorders, social-emotional complications of ADHD and learning problems, parent-teen conflict, and parent stresses) that require a family systems approach to assessment and treatment, i.e., viewing the problems and the solutions within the family-social context in which they arise. Most physicians are not trained in family systems-family interviewing techniques, which are needed for these clinical situations.

The goal of this workshop is to teach these techniques. Specifically, attendees will learn basic family systems principles, three models of interviewing techniques, the use of family drawings and genograms, and how to deal with the difficult family.

The workshop will be very interactive. Teaching techniques include case studies, brief didactics, videotapes of family interviews, and extensive handouts. Attendees should bring their own case studies for discussion.

William Coleman, Dept. of Pediatrics, Univ. of North Carolina, Chapel Hill, NC

Despite clinicians' universal intentions to provide excellent care, actual care often falls short. These gaps in care lead to worsened health status, decreased satisfaction, increased costs, and clinician and staff distress. Achieving major enhancements in care requires substantial restructuring of the approach to care and changing office systems to better meet patient, family, and staff needs.

The National Initiative for Children's Healthcare Quality (NICHQ) seeks to eliminate the gap between what is and what can be in health care for all children by raising the will to improve, developing better strategies to accomplish change, and directly assisting practices in their improvement activities. This direct assistance entails measuring current performance, training practice staff about how to achieve change, providing expertise in providing tools and materials to enhance improvement, and supporting change through the formation of "collaborative learning groups." NICHQ, building on the practice guidelines of the American Academy of Pediatrics, has launched a new project to transform care for children with ADHD.

The objective of this workshop is to provide participants with the fundamentals of how to promote change in primary care settings for children so that they better meet the needs of children, families, clinicians, and staff. We will build on the example of ADHD, and give participants the opportunity to plan actual changes they might bring back to their care settings.

C. J. Homer, P. Margolis, P. Heinrich, L. White, J. Perrin. National Initiative for Children's Healthcare Quality, Boston, MA; Chapel Hill, NC; and Seattle, WA; Mass General Hospital for Children, Boston, MA

The objective of this workshop will be to introduce strategies to teach pediatric residents about the Healthy Steps approach of developmentally-oriented, primary care. With the support of the Commonwealth Foundation and other funders, we developed an innovative program (presently in 24 practices nationally) called "Healthy Steps" (HS). HS enhances services for young children in primary care through such strategies as teachable moments, promotion of early literacy, parent handouts, and other family supports. To implement HS, we have created an interactive curriculum involving video vignettes of children's behavior and a CD-ROM to help pediatricians better understand and respond to the social, emotional, fine motor, and cognitive development of infants and toddlers. Specifically, the curriculum emphasizes improving observational skills and understanding the meaning of children's behavior and development.

The curriculum and associated videos have been presented to more than 50 faculty of pediatric residency training programs and are presently used in a variety of settings, including pre-clinic primary care conferences or as part of developmental and behavioral pediatrics rotation. This workshop will provide the tools to enhance resident training in developmental and behavioral issues through its innovative, multi-media, interactive approach.

Barry Zuckerman, Steven Parker, Margot Kaplan Sanoff, Marilyn Augustyn. Boston University, Boston MA

Increasingly, scientific evidence is becoming available that links chronic diseases such as atherosclerosis, neuropsychiatric disorders and certain malignancies with infectious roots. Faculty will expose the fascinating existing information and help put novel findings and theories in perspective.

Are All Diseases Infectious?
Bennett Lorber, Temple University School of Medicine, Philadelphia, PA

Chlamydia pneumoniae and Atherosclerosis: Weighing the Evidence
Thomas C. Quinn, Johns Hopkins University School of Medicine, Baltimore, MD

Epstein-Barr Virus, Lymphoproliferation and Cancer
John L. Sullivan, University of Massachusetts School of Medicine, Worcester, MA

The objective of this workshop is to address key issues concerning the use and safety of dietary supplements in infants and children. There is a growing body of evidence that nutrients and other bioactive components of foods play a significant role in health promotion and disease prevention in adults and this information has increased the use of dietary supplements in infants and children. However, little is known about the interaction between the use of many of these supplements and developmental physiology and behavior in children. Such knowledge is critical when evaluating either the justification or safety of this trend. Topics to be addressed at the workshop include: 1) Current usage patterns among infants, children and adolescents; 2) Evidence-based justification for dietary supplement use at various developmental stages; 3) Age-dependent factors influencing bioavailability, pharmacology and safety; 4) Behavioral factors that impact attitudes and beliefs about dietary supplements; 5) Biomarkers for the assessment of efficacy and safety; and, 6) Identification of research needs.

P. M. Coates, D. J. Raiten and M. F. Picciano, Office of Dietary Supplements, National Institutes of Health & Office of Prevention Research and International Programs, National Institutes of Child Health and Human Development, Bethesda, MD

Assessing adolescents for use of alcohol and drugs presents a major challenge for clinicians in the current primary care environment that emphasizes patient volume. The goal of this workshop is to develop clinical skills in using brief structured assessment tools to assess adolescents for drug or alcohol use. The workshop is intended for pediatric clinicians and pediatric educators.

Participants will learn: (1) To use structured assessment instruments that have been validated for adolescents, and (2) Strategies for interviewing adolescents. This workshop will use a standardized case, The Pinpoint Pupil, along with additional audio-visual materials for skills development. Workshop participants will be invited to discuss the management of an adolescent who is brought to a Pediatricians office because of marijuana use. The CRAFFT mnemonic will be presented. Participants will then watch video tapes of interactions between clinicians and adolescents, and discuss the subtleties of interviewing techniques and their impact on information revealed by the patient. The workshop will conclude with a discussion of how these techniques can be applied in the office and in teaching pediatric residents. Each participant will receive a copy of the complete teaching module, with handouts and references, for use in his or home institution.

S. Levy, B. Vaughan, A. Arneill, J. R. Knight, Department of Pediatrics, Harvard Medical School; Division of General Pediatrics, Children's Hospital, Boston, MA

The Human Genome Project is impacting every aspect of medicine. Dr. Craig Venter, President of Celera Genomics, one of the chief architects of this venture, will discuss the accomplishments of the human genome project and implications for future impact on health and disease in this special one-hour state of the art lecture.

Sequencing the Human Genome
J. Craig Venter, President, Celera Genomics, Rockville, MD

Supported in part by an educational grant from the Columbus Children's Hospital, Columbus, OH

Trauma is the leading cause of death in children and severe traumatic brain injury is a key contributor to this mortality and important morbidity. This session will focus on novel developments in our understanding of the mechanisms of secondary damage that evolve during the acute phase after injury and novel therapeutic approaches to this important condition-including therapies targeting brain swelling and delayed neuronal death. Finally, reorganization of the injured brain and potential therapeutic implications in the subacute/chronic phase will also be discussed.

Key Mechanisms of Secondary Damage After Traumatic Brain Injury in Infants and Children
Patrick M. Kochanek, Safar Center for Resuscitation Research, University of Pittsburgh School of Medicine and Children's Hospital of Pittsburgh, Pittsburgh, PA

Secondary Cerebral Swelling and the Use of Hypertonic Saline
Bradley Peterson, Children's Hospital and Health Center, San Diego, CA

Understanding and Targeting Neuronal Death
Robert S.B. Clark, Children's Hospital of Pittsburgh, Pittsburgh, PA

Reorganization of the Injured Brain: Therapeutic Implications
Harvey Levin, Baylor College of Medicine, Houston, TX

Discussion

The roles of nature and nurture in shaping behavior are complex and our understanding of them is constantly expanding. Exciting recent findings have given us new perspectives on biologic influences on brain functioning and subsequent behavior. Genetic conditions can be reflected in clearly identifiable behavioral phenotypes. Prenatal exposure to nicotine can have effects that are measurable in adolescence, and low level exposure to environmental toxins are impacting cognitive and behavioral functioning of the current generation. Three outstanding speakers will discuss these advances in our knowledge of neuroscience and their implications for the identification and treatment of a variety of neurodevelopmental conditions.

Overview
Daniel Lee Coury, Children's Hospital, Columbus, OH

Fragile X Syndrome: A Model of Gene-Brain Behavior Relationships
Randi J. Hagerman, University of California at Davis Medical Center, Sacramento, CA

Tobacco, Nicotine and Fetal Brain Damage: The Smoking Gun in ADHD and SIDS
Theodore Slotkin, Duke University Medical Center, Durham, NC

Neurotoxicity of Low-Level Exposure to Pesticides and PCBs
Philip John Landrigan, Center for Children's Health & the Environment, Mt. Sinai School of Medicine, New York, NY

The role of experience and the environment in early child development has long been appreciated, but it has been likened to loading software on a computer.  Recent research in neurobiology suggests that early experiences are not only loading software but actually changing the hard wiring of the brain.  Many of the brain’s pathways are in place by three years of age.  What are the implications for this research?  Do these pathways continue to change and evolve with experience? What are the effects of early insults on brain development? This program will focus on the Institute of Medicine Report From "Neurons to Neighborhoods".  The speakers will focus on what is known about the neurobiology of brain development and the implications this research has on child development programs.  The session will highlight how the current knowledge of brain development will impact future research as well as how it may translate into public policy.